Pilot Study of the QI Device for Monitoring of Patients With Congestive Heart Failure

Completed

Conditions studied: Heart Failure

In brief

The present study proposes to utilize a novel, wearable device, QI Device, which has multiple sensors embedded in a "wrist-watch" in order to explore its monitoring capabilities in individuals with congestive heart failure.

Key facts

Study ID

NCT02343523

Run by

Scripps Translational Science Institute

People needed

13

Starts

2015-01-01

Expected to finish

2015-09-01

Last updated by the study team

2016-05-05

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults over age 18
• Own, and comfortable using, a home computer with internet access (Phase 2 only)
• Acute hospitalization with a primary diagnosis of acute decompensated heart failure (ADHF) diagnosed on the basis of all of the following:
• Symptoms:
• Onset or worsening of dyspnea within the past 2 weeks
• Physical exam (at least 1 present):
• Rales/ Crackles on auscultation
• Elevated JVP > 10 cmH2O
• Weight gain
• LE edema
• Diagnostic imaging/ labs (at least 1 present):
• Evidence of pulmonary congestion or edema on chest X-ray/ chest CT
• Elevated BNP or NT-pro-BNP (age-adjusted)

You may not qualify if…

• Psychological or social situation that would make the study difficult for the patient
• Inability to consent
• Chronic atrial fibrillation or other dysrhythmia with a high (>10%) burden of ectopic beats.
• Pregnant women
• Pneumonia - currently, or within the past 30 days
• Non-cardiogenic pulmonary edema (e.g. ARDS)
• Interstitial lung disease
• End-stage renal disease and on Hemodialysis

Where it is running

• Scripps Health — San Diego, California, United States

Full record on ClinicalTrials.gov

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